The US FDA Approves Incyte’s Zynyz to Treat Adults with Squamous Cell Anal Carcinoma (SCAC)

Shots:FDA has approved Zynyz (retifanlimab-dlwr) + Pt-based CT as 1L treatment of inoperable locally recurrent or metastatic SCAC, & as monotx. for locally recurrent or metastatic SCAC progressing on or intolerant to Pt-based CT; EMA & PMDA’s application are under reviewApproval was based on P-III (POD1UM-303/InterAACT2) trial assessing Zynyz + Pt-based CT vs…

ByRidhi RastogiMay 16, 2025

INSIGHTS+

PharmaShots’ Key Highlights of First Quarter 2025

Shots:  Q1’2025 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The talk of the town remained Intra-Cellular Therapies’ acquisition by Johnson & Johnson for ~$14.6B The quarter highlighted breakthrough results, pivotal clinical data, including Eli Lilly and Incyte's P-III Study Data of Baricitinib to treat Alopecia Areata PharmaShots brings…

ByRidhi RastogiApril 1, 2025

News

Incyte Reports Topline Data from P-III (STOP-HS1 & STOP-HS2) Trials of Povorcitinib (INCB054707) for Hidradenitis Suppurativa (HS)

Shots:The 2 P-III (STOP-HS1 & STOP-HS2) trials assessed povorcitinib (45 or 75mg, QD, PO) vs PBO in mod. to sev. HS pts (≥18yrs.; n=600 each) for 12wks., followed by 42wk. extension & 30-day follow-up STOP-HS1 met its 1EP, with povorcitinib (45 mg/75 mg) showing higher HiSCR50 rates at Wk. 12 (40.2%/40.6% vs 29.7%), while…

ByRidhi RastogiMarch 18, 2025

News

Eli Lilly and Incyte Highlight P-III (BRAVE-AA-PEDS) Trial Data of Baricitinib for Alopecia Areata at AAD 2025

Shots:The P-III (BRAVE-AA-PEDS) trial assessed baricitinib (2 or 4mg, QD, PO) vs PBO in 257 pts (12 to <18yrs.) with severe AA, where 89% had significant scalp hair loss, 65% had minimal/no eyebrow hair, & 57% had minimal/no eyelash hair with ClinRO of 2/3; next cohort (6 to <12yrs) enrollment to start in 2026…

ByRidhi RastogiMarch 11, 2025

News

Incyte Highlights P-III (TRuE-PN) Clinical Program Data of Opzelura (1.5% Ruxolitinib Cream) for Prurigo Nodularis (PN) at AAD 2025

Shots:Incyte has reported P-III (TRuE-PN: TRuE-PN1 & TRuE-PN2) clinical program data assessing Opzelura (BID) vs vehicle in ~180 PN pts (≥18yrs.) each for 12wks TRuE-PN1 showed ≥4-point WI-NRS4 improvement at 12wks. (1EP; 44.6% vs 20.6%), with itch relief by Day 7 (22.4% vs 8.0%). It also met its 2EPs, incl. higher IGA-CPG-S-TS score…

ByRidhi RastogiMarch 10, 2025

News

Elanco Launches Pet Protect Supplement Line for Dogs and Cats

Shots:Elanco has introduced Pet Protect, a veterinarian-formulated supplement line with scientifically-backed ingredients & NASC quality seal for dogs & cats designed to target their various health needs Pet Protect line incl. supplements like Synovi G3 formula (hip & joint support), DVM Daily Soft Chews (multivitamins) & Lactoquil (digestive health) to maintain GI health…

ByRidhi RastogiFebruary 21, 2025

News

Incyte Partners with Genesis to Develop and Commercialize Novel Small Molecules Using Genesis’ GEMS AI Platform

Shots:Incyte has partnered with Genesis to advance research, discovery, & development of novel small molecules using GEMS (Genesis Exploration of Molecular Space) AI platform, initially focusing on targets selected by Incyte As per the agreement, Incyte will gain exclusive rights to develop & commercialize products arising from this deal in exchange for $30M…

ByRidhi RastogiFebruary 21, 2025

News

Incyte and Syndax Receives US FDA Approval for Niktimvo (axatilimab-csfr) to Treat Chronic Graft-Versus-Host Disease (GvHD)

Shots: Based on P-II (AGAVE-201) study, Niktimvo got FDA approval to treat chronic GvHD patients who failed at least two lines of previous therapy Niktimvo patients (0.3 mg/kg, Q2W, n=79) achieved 75% ORR in 6mos. with 1.5mos. mToR; 60% maintained response at 12mos. Study also met key exploratory EPs, 56% patients achieved ≥7-point improvement in…

ByDipanshu DixitAugust 14, 2024

TOP 20

Top 20 Immunology Companies of 2024

Shots:Immunology remains one of the most explored therapy areas. Companies focusing on immunology are steadfastly working to advance treatment options by developing drugs, vaccines, and antibodiesIn 2023, the global immunology market size was valued at $98.22B and expected to register $263.22B by 2033, with a CAGR of 10.36% from 2024 to 2033. AbbVie…

ByPrince GiriJuly 25, 2024

INSIGHTS+

PharmaShots’ Key Highlights of Second Quarter 2024

Shots:The second quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Vertex’ acquisition of Alpine Immune Sciences for ~$4.9BThis quarter also showcased multiple clinical trial results including Moderna’s P-III Study Data of mRNA-1283 Vaccine to Prevent COVID-19…

BySenior EditorJuly 2, 2024

The US FDA Approves Incyte’s Zynyz to Treat Adults with Squamous Cell Anal Carcinoma (SCAC)

PharmaShots’ Key Highlights of First Quarter 2025

Incyte Reports Topline Data from P-III (STOP-HS1 & STOP-HS2) Trials of Povorcitinib (INCB054707) for Hidradenitis Suppurativa (HS)

Eli Lilly and Incyte Highlight P-III (BRAVE-AA-PEDS) Trial Data of Baricitinib for Alopecia Areata at AAD 2025

Incyte Highlights P-III (TRuE-PN) Clinical Program Data of Opzelura (1.5% Ruxolitinib Cream) for Prurigo Nodularis (PN) at AAD 2025

Elanco Launches Pet Protect Supplement Line for Dogs and Cats

Incyte Partners with Genesis to Develop and Commercialize Novel Small Molecules Using Genesis’ GEMS AI Platform

Incyte and Syndax Receives US FDA Approval for Niktimvo (axatilimab-csfr) to Treat Chronic Graft-Versus-Host Disease (GvHD)

Top 20 Immunology Companies of 2024

PharmaShots’ Key Highlights of Second Quarter 2024

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